Back to resultsHFCWO in Hospitalized Asthmatic Children
Primary Purpose
Bronchial Asthma, Asthma, Status Asthmaticus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VEST
Sponsored by
About this trial
This is an interventional treatment trial for Bronchial Asthma focused on measuring Asthma, Bronchial Disease, Status Asthmaticus, High Frequency Chest Wall Oscillation, the Vest, HFCWO
Eligibility Criteria
Inclusion Criteria:
- Any pediatric patient between the ages of 18 months and 18 years admitted to Winthrop University Hospital's pediatric floor or intensive care unit with a diagnosis of asthma or reactive airway disease
Exclusion Criteria:
- Patients with chronic, comorbid respiratory conditions (e.g., cerebral palsy, cystic fibrosis)
- Those who regularly use HFCWO
- Any patient exhibiting an absolute contraindication to HFCWO therapy
- Absolute contraindications to using HFCWO include head and neck injury prior to stabilization, and active hemorrhage with hemodynamic instability
Sites / Locations
- Winthrop University Hospital, Winthrop Pediatric Associates
- Winthrop University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Vest Arm
Control
Arm Description
HFCWO treatments 2-3 times daily 15 minutes per treatment via the VEST
Historical control for PICU asthma patients
Outcomes
Primary Outcome Measures
The Primary Endpoint Will be Time to Readiness for Discharge.
Days in the hospital prior to patient being clinically ready to discharge
Secondary Outcome Measures
Secondary Endpoint Total Hospital Length of Stay
Seconadary endpoint was Total Hospital length of stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00722020
Brief Title
HFCWO in Hospitalized Asthmatic Children
Official Title
High Frequency Chest Wall Oscillation in Hospital Management of Asthmatic Children
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hill-Rom
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine whether or not high frequency chest wall oscillation (in the form of the VestTM) is superior to regular asthma therapy in the management of children hospitalized with moderate to severe asthma.
Detailed Description
A historically controlled pilot study was conducted in pediatric patients 18 months to 18 years of age hospitalized with a diagnosis of asthma or reactive airway disease and admitted to the pediatric intensive care unit. Upon receiving informed consent, patients were treated with HFCWO therapy via the VEST. The primary endpoint was time to readiness for discharge, lack of need for continued supportive care (e.g., intravenous fluid or oxygen), and bronchodilator treatments spaced at least four hours apart.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchial Asthma, Asthma, Status Asthmaticus
Keywords
Asthma, Bronchial Disease, Status Asthmaticus, High Frequency Chest Wall Oscillation, the Vest, HFCWO
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vest Arm
Arm Type
Experimental
Arm Description
HFCWO treatments 2-3 times daily 15 minutes per treatment via the VEST
Arm Title
Control
Arm Type
No Intervention
Arm Description
Historical control for PICU asthma patients
Intervention Type
Device
Intervention Name(s)
VEST
Other Intervention Name(s)
Hill-Rom Vest(tm)
Intervention Description
15 minutes of HFCWO via the Vest 2-3 times daily
Primary Outcome Measure Information:
Title
The Primary Endpoint Will be Time to Readiness for Discharge.
Description
Days in the hospital prior to patient being clinically ready to discharge
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Secondary Endpoint Total Hospital Length of Stay
Description
Seconadary endpoint was Total Hospital length of stay
Time Frame
30 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any pediatric patient between the ages of 18 months and 18 years admitted to Winthrop University Hospital's pediatric floor or intensive care unit with a diagnosis of asthma or reactive airway disease
Exclusion Criteria:
Patients with chronic, comorbid respiratory conditions (e.g., cerebral palsy, cystic fibrosis)
Those who regularly use HFCWO
Any patient exhibiting an absolute contraindication to HFCWO therapy
Absolute contraindications to using HFCWO include head and neck injury prior to stabilization, and active hemorrhage with hemodynamic instability
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Roberts, MD
Organizational Affiliation
Winthrop University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Winthrop University Hospital, Winthrop Pediatric Associates
City
Long Island City
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Winthrop University Hospital
City
Long Island City
State/Province
New York
ZIP/Postal Code
11501
Country
United States
12. IPD Sharing Statement
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HFCWO in Hospitalized Asthmatic Children
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